Recall Z-2160-2019 · NKB Thoracolumbosacral Pedicle Screw System
Howmedica Osteonics Corp.
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
| Date | Jun 18, 2019 |
| Status | Terminated |
| Reason | Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length. |
| Root cause | Labeling mix-ups |
| Action | 1. Please note this product has already been removed by your local Stryker Sales Representative and/or Stryker Branch or Agency. This communication is being made for notification purposes only; there are no additional product return requirements for this matter. 2. Please assist us in meeting our regulatory obligation by completing and signing the enclosed Product Recall Acknowledgment Form and email a copy to Stryker Spine at SpineRegulatoryActions@Stryker.com or fax the form to 201-575-4675. If you have any questions, please contact Christa Joisil or Matthew Kelleher from the Regulatory Co |
| Quantity | 11 |
| Distribution | US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory Stryker Corporation, May 16, 2017 |